{"id":64864,"date":"2022-06-18T00:55:59","date_gmt":"2022-06-17T22:55:59","guid":{"rendered":"http:\/\/www.veeva.com\/eu\/?page_id=64864"},"modified":"2026-01-30T16:05:41","modified_gmt":"2026-01-30T15:05:41","slug":"kcr-three-lessons-from-our-journey-to-modernize-and-unify-clinical-trial-operations","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/kcr-three-lessons-from-our-journey-to-modernize-and-unify-clinical-trial-operations\/","title":{"rendered":"KCR"},"content":{"rendered":"

\nKCR is a medium-sized CRO with a global reach. They use the ³Ô¹Ï±¬ÁÏ Clinical Platform<\/a> to drive their digital
\ntransformation. The team has managed dozens of studies and hundreds of thousands of documents, all while
\ndramatically improving TMF quality measures.\n<\/p>\n

\nTo support a unified approach, KCR implemented ³Ô¹Ï±¬ÁÏ eTMF in 2014, followed by ³Ô¹Ï±¬ÁÏ CTMS in 2019 and
\n³Ô¹Ï±¬ÁÏ EDC in 2021. Magdalena Matusiak, KCR\u2019s head of data science and documentation services, shares three
\nlessons for success.\n<\/p>\n

\n\t\"\"\n<\/div>\n
\n\t\"\"<\/p>\n
\n\t\tTAKEAWAY #1<\/strong>
\n\t\tBefore implementing new technology, understand the capabilities and use those learnings to
\n\t\tdevelop new processes to maximize value.\n\t<\/div>\n<\/div>\n

\nBefore implementing ³Ô¹Ï±¬ÁÏ CTMS, the KCR team learned the full range of capabilities within the application.
\nAfter that, Matusiak said, \u201cWe thought about how to change our processes, approaches, and SOPs so we could
\nreally benefit from the technology.\u201d\n<\/p>\n

\n³Ô¹Ï±¬ÁÏ CTMS became the team\u2019s communication and process management tool through which subject data
\nand trial documentation flow. They also established automated workflows so that actions trigger downstream
\nactivities throughout the ³Ô¹Ï±¬ÁÏ Clinical Platform, rather than relying on email and other external channels for study
\ncommunication.\n<\/p>\n

\nFor example, a case report form that marks a study\u2019s first subject first visit
\nin ³Ô¹Ï±¬ÁÏ EDC is automatically visible in ³Ô¹Ï±¬ÁÏ CTMS. Once the milestone
\nis complete, the system generates an automated request in ³Ô¹Ï±¬ÁÏ eTMF for
\nmilestone-associated documentation.\n<\/p>\n

\n\t\"\"\n<\/div>\n
\n\t\"\"<\/p>\n
\n\t\tTAKEAWAY #2<\/strong>
\nDefine clear responsibilities for each role, and empower subject
\nmatter experts to take ownership of their documentation.\n\t<\/div>\n<\/div>\n

\nKCR established new teams with clear roles, as well as guidelines for processes such as data entry and quality
\ncontrol (QC). For example, clinical trial assistants were previously responsible for all documentation, but KCR
\ncreated a new clinical trial documentation team with responsibilities divided among subject matter experts.\n<\/p>\n

\n\u201cDefining clear roles and responsibilities is the key to success when we think about implementation of new
\ntechnology,\u201d Matusiak said.\n<\/p>\n

\n\t\"\"\n<\/div>\n
\n\t\"\"<\/p>\n
\n\t\tTAKEAWAY #3<\/strong>
\n\t\tUse technology to increase transparency and aggregate data to measure success.\n\t<\/div>\n<\/div>\n

\n The clinical trial documentation team helped define and apply KPIs to support the technology implementation.
\nThey also aggregated data from their ³Ô¹Ï±¬ÁÏ applications to drive improvements such as increased TMF health.
\nIn three years, the team nearly doubled timeliness and completeness of eTMF documents and maintained high
\nquality.\n<\/p>\n

\n\u201cEven the best technology is useless if we don\u2019t have data in sight,\u201d Matusiak said. \u201cData helps to ensure success
\nduring technology implementation and beyond.\u201d\n<\/p>\n

\n\t\"\"\n<\/div>\n

\nLearn more about standardizing clinical trials for efficient studies<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

KCR shares three lessons from modernizing and unifying clinical trial operations.<\/p>\n","protected":false},"featured_media":62626,"parent":0,"template":"","product-link-list":[],"class_list":["post-64864","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64864"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":4,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64864\/revisions"}],"predecessor-version":[{"id":82874,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/64864\/revisions\/82874"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/62626"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=64864"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=64864"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}